Industry news

• Relay adds executives to its chemistry, R&D teams as it transitions to the development stage

  10 December 2018 Conor Hale / FierceBiotech

  Former Fierce 15 winner Relay Therapeutics has brought on Verastem’s Mahesh Padval, Ph.D., and Eli Lilly’s Mary Mader, Ph.D., to boost its drug discovery and development operations in oncology as it begins to transition to an R&D-stage biotech.

• U.K. sets out digital, data-driven plan to accelerate R&D

  10 December 2018 Nick Paul Taylor / FierceBiotech

  The U.K. government has set out how it plans to use data and digital technologies to attract clinical trials. Near-term plans include the creation of a system for assessing study feasibility and an app to connect patients to studies.

• Scientists developed the first fully personalized tissue implant

  07 December 2018 GMP News

  In a new study, Tel Aviv University (Israel) researchers reveal how they invented the first fully personalized tissue implant, engineered from a patient’s own materials and cells. The new technology makes it possible to engineer any kind of tissue implant from one small fatty tissue biopsy.

• Five Russian startups present their projects at Cambridge Biomedical Campus

  07 December 2018 GMP News

  Five Russian startups, the winners of the Startup Challenge accelerator, organised jointly by the Skolkovo Foundation and multinational pharma giant AstraZeneca, are showcasing their inventions at the International Future Healthcare Forum in the British city of Cambridge (UK) this week.

• Researchers published the study on fractional-dose yellow fever vaccination

  06 December 2018 GMP News

  Researchers from Leiden University Medical Center (Leiden, the Netherlands) studied 10 year follow-up data on a subgroup of patients from the trial to evaluate whether fractional-dose vaccination conferred long-term immunity.

• Scientists developed new mathematical method for precision medicine

  06 December 2018 GMP News

  A research team from MedUni Vienna’s Institute of Medical Statistics (Austria) presented new mathematical methods that efficiently identify the characteristics that are relevant for such predictions. These methods can also be used to calculate the range of statistical variation of these predictions.

• Pfizer wins blockbuster Lyrica patent extension to safeguard sales till June

  05 December 2018 Eric Sagonowsky / FiercePharma

  Pfizer, looking to protect billions in Lyrica sales, has been gunning for a 6-month pediatric exclusivity extension for its top drug. And on Tuesday, the FDA came through in favor of the drugmaker.

• EMA published new guideline on the environmental risk of human medicines

  05 December 2018 GMP News

  The European Medicines Agency (EMA) has published a iconrevision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these substances have shown direct effects on wildlife at or below the concentrations found in water and soil.

• Scientists developed new mathematical method for precision medicine

  04 December 2018 GMP News

  A research team from MedUni Vienna’s Institute of Medical Statistics (Austria) presented new mathematical methods that efficiently identify the characteristics that are relevant for such predictions. These methods can also be used to calculate the range of statistical variation of these predictions.

• Five EU countries were included into the EU-US mutual recognition agreement

  04 December 2018 GMP News

  Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the European Union and the United States on 16 November and Estonia on 28 November 2018. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and as of today, the FDA will rely on a total of 20 Member States whose inspection results can replace their own inspections.